Spatial Cognitive Training for Chronic Vestibular Disorders

NCT03950648 | Withdrawn

• 1 other identifier: STUDY19030436
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

Conditions

Vestibular Abnormality; Cognitive Training

Outcome Measures

Primary Outcomes (6)

• Change from baseline in Dizziness Handicap Inventory

  Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

  Baseline vs immediately post-training

• Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory

  Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

  Immediately post-training to 3 months post-training

• Change from baseline in Dynamic Gait Index

  Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

  Baseline vs immediately post-training

• Change from immediate post-training to 3-months post-training in Dynamic Gait Index

  Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

  Immediately post-training to 3 months post-training

• Change from baseline in Four Square Step Test

  Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

  Baseline vs immediately post-training

• Change from immediate post-training to 3-months post-training in Four Square Step Test

  Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

  Immediately post-training to 3 months post-training

Secondary Outcomes (10)

• Change from baseline in Money Road Map Test

  Baseline vs immediately post-training

• Change from immediate post-training to 3-months post-training in Money Road Map Test

  Immediately post-training to 3 months post-training

• Change from baseline in Benton Visual Retention Test

  Baseline vs immediately post-training

• Change from immediate post-training to 3-months post-training in Benton Visual Retention Test

  Immediately post-training to 3 months post-training

• Change from baseline in modified Clinical Test of Sensory Organization and Balance

  Baseline vs immediately post-training

Study Arms (1)

Spatial Cognitive Training

EXPERIMENTAL

map reading and route-learning skills

Behavioral: Spatial Cognitive Training

Interventions

Spatial Cognitive Training BEHAVIORAL

map reading and route-learning skills

Spatial Cognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic vestibular disorder (\>6months \& diagnosis from laboratory testing by neuro-otologist)

You may not qualify if:

• Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Johns Hopkins University: collaborator

Study Officials

• Brooke Klatt, PhD, PT

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 15, 2019
• Study Start: June 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: April 22, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year